FDA Approves LENALIDOMIDE — Devatis Inc.
Devatis Inc. secured FDA approval for its oral Lenalidomide generic, positioning the manufacturer to capture potential market share in the myeloma treatment space amidst anticipate…
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Devatis Inc. secured FDA approval for its oral Lenalidomide generic, positioning the manufacturer to capture potential market share in the myeloma treatment space amidst anticipate…
On April 17, 2025, Bristol received approval for a new drug application (NDA 220073), a development that is poised to reshape the competitive landscape for the specified therapeuti…
# FDA Approves Generic Imatinib Mesylate Camber Pharmaceuticals, Inc. has received FDA approval for its generic formulation of imatinib mesylate, an oral tyrosine kinase inhibitor…
Fresenius Kabi USA announced on March 14, 2025, the FDA approval of its biosimilar TOCILIZUMAB (TYENNE), a fully human monoclonal antibody for injection. This approval introduces a…
# FDA Approves Scienture LLC's ARBLI (Losartan Potassium) for Oral Use The U.S. Food and Drug Administration has approved Scienture LLC's ARBLI (losartan potassium) oral formulati…
# FDA Approves BIOCON PHARMA's Generic Lenalidomide, Expanding Access to Key Multiple Myeloma Treatment BIOCON PHARMA INC. has received FDA approval for its generic lenalidomide o…
# FDA Approves Generic Bosentan; Lupin Pharmaceuticals Enters Pulmonary Hypertension Market Lupin Pharmaceuticals, Inc. has received FDA approval for generic bosentan oral tablets…
Supernus Pharmaceuticals, Inc. announced the FDA approval of ONAPGO (apomorphine hydrochloride) for subcutaneous administration, a launch expected to bolster its market share and d…
Macleods Pharmaceuticals Limited obtained FDA approval for its generic Tramadol Hydrochloride oral tablets (ANDA209404), a milestone likely to drive revenue growth and strengthen i…
Rising Pharma Holdings, Inc. received FDA approval Monday to market its generic version of the antihypertensive and diuretic Spirionolactone (ANDA219494), potentially broadening ac…
# FDA Approves Daiichi Sankyo's DATROWAY (datopotamab deruxtecan) for Oncology Treatment Daiichi Sankyo Inc. received FDA approval for DATROWAY (datopotamab deruxtecan), an intrav…
Yichang Humanwell announced the FDA’s approval of NDA ANDA219072 on January 16, setting the stage for a new market entrant and driving shareholder value amidst the intensifying gen…
On December 27, 2024, the FDA approved **E.R. Squibb & Sons, L.L.C.**’s OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy), a novel subcutaneous formulation of its flagship immunoth…
# FDA Approves Generic Drug Application for Aurobindo Pharma Aurobindo Pharma Ltd. received FDA approval for ANDA215971 on December 26, 2024, expanding its generic pharmaceutical …
The FDA’s approval of Zenocutuzumab (Bizengri) on December 4 grants Merus US, Inc. commercial rights to a first-in-class therapy for NRG1 fusion-positive cancers, positioning the c…
Biocon Biologics Inc. announced the FDA approval of YESINTEK (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, a strategic expansion into the lucrative autoim…
Wuxi Fortune Pharmaceutical has secured FDA approval for its generic Mycophenolate Mofetil (ANDA 214079), signals an escalation in its U.S. market presence. The approval will likel…
On November 7, 2024, Azurity Pharmaceuticals received FDA approval for Danziten (nilotinib), expanding access to this oral therapy amid a competitive climate for chronic myeloid le…
# FDA Approves UBI Pharma's Generic Leuprolide Acetate Injection The FDA has approved UBI Pharma Inc.'s abbreviated new drug application (ANDA) for leuprolide acetate subcutaneous…
# FDA Approves AbbVie's VYALEV for Parkinson's Disease Treatment AbbVie Inc. received FDA approval for VYALEV (foscarbidopa/foslevodopa) subcutaneous injection, a novel formulatio…